PEP Buddy for COPD

(PEPR Trial)

Not yet recruiting at 1 trial location

Overseen By Robert M Burkes, MD MS

Age: 18+

Sex: Any

Trial Phase: Phase 2 & 3

Sponsor: VA Office of Research and Development

Disqualifiers: Other lung diseases, Neurological conditions, Life expectancy <1 year, Cancer beyond Stage I, Memory loss, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

In this study, the investigators will test Veterans with COPD in Pulmonary Rehabilitation. Between two groups, the investigators will give one group a device that assists with breathing and symptoms and the other receives a 'sham' device which does not provide these benefits. The investigators will test to see if the symptoms and exercise capacity of the group who receives this device improves faster in Pulmonary Rehabilitation and has longer lasting benefits after the end of Pulmonary Rehabilitation.

Who Is on the Research Team?

Robert Matthew Burkes, MD MS

Principal Investigator

Cincinnati VA Medical Center, Cincinnati, OH

Are You a Good Fit for This Trial?

Inclusion Criteria

FEV1 <80% predicted

Veteran

I have been referred to a lung rehab program for my COPD.

Exclusion Criteria

Those shown shown to have memory loss of MOCA testing

My lung condition is caused by swallowing problems or nerve issues affecting my face or throat.

Those with a life expectancy of <1 year

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pulmonary Rehabilitation

Participants undergo pulmonary rehabilitation with either the PEP Buddy device or a sham device

12 weeks

Visits at Weeks 3, 6, 9, and 12

Follow-up

Participants are monitored for changes in quality of life and functional capacity after pulmonary rehabilitation

12 months

Assessments at six and twelve months

What Are the Treatments Tested in This Trial?

Interventions

• PEP Buddy

How Is the Trial Designed?

Group I: PEP Buddy Experimental Treatment 1 Intervention

This arm will be provided with a portable device that provides 5-7 cm H2O of expiratory pressure, to be used when subjectively breathless

Group II: Sham Placebo Group 1 Intervention

This arm will be provided with a portable device that appears the same as PEP Buddy but provides 1-3 cm H2O of expiratory pressure, to be used when subjectively breathless

Who Is Running the Clinical Trial?

VA Office of Research and Development

Lead Sponsor

Trials

1,691

Recruited

3,759,000+